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FDA seize contaminated ultrasound gel

By Tim Sandle
Posted Apr 19, 2012 in Health
Federal law enforcement officials, under the FDA, have seized several lots of ultrasound gel from a New Jersey company after the product tested positive for bacterial contamination.
In fact, 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa. Upon investigation, the ultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca.
The Food and Drug Administration says the gel tested positive for two strains of dangerous bacteria. The agency reports at least 16 patients at one hospital were infected with bacteria from the product. The gel is used to enhance ultrasound medical images.
The FDA collected and tested unopened bottles of Other-Sonic Generic Ultrasound Transmission Gel at the reporting hospital and at Pharmaceutical Innovations Inc.’s facility. The FDA’s testing revealed that the finished product contained significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca. This result suggests that the source of this contamination occurred during the manufacturing process.
U.S. marshals seized all lots of Other-Sonic generic ultrasound gel made between June 2011 and December 2011 by Newark, N.J.-based Pharmaceutical Innovations.
The FDA urges health care professionals not to use containers labeled with lot numbers: 060111, 090111 and 120111. Doctors should identify and assess the health of patients who may have been treated with contaminated gel.
For further details, see CBS News

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